Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children

NCT03812315 | Completed Phase 2

• 1 other identifier: Propolis in 2 vehicles
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Propolis is a natural product collected by bees to seal holes and repair structures in their hives. Recently it has attracted much attention as useful substance applied in medicine and cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable part of medicine and therefore attempts were made to use propolis in dentistry, as well. Purpose of the study: to investigate the effect of propolis administered in chewing gum as compared to that incorporated in mouthwash on plaque accumulation, microbial population and patient acceptance.

Conditions

Early Childhood Caries

Keywords

Propoplis; chewing gum; mouthwash; high caries risk children; antimicrobial

Outcome Measures

Primary Outcomes (3)

• Change in Plaque Accumulation

  All children will be examined clinically using the Plaque Control record (O' Leary, Darke and Naylor). The child will be asked to chew a disclosing tablet and let it mix with saliva for 30 seconds and spit it out. Each tooth is divided into 4 surfaces; the plaque accumulations on all surfaces will be scored. The number of positively scored units is divided by the total number of tooth surfaces evaluated, and the result is multiplied by 100 to express the index as a percentage.

  Baseline and after 2 weeks

• Microbiological Sampling of Dental Plaque

  On the day of sampling, each child will refrain from tooth brushing in the morning, eating or drinking (except water) at least two hours before sampling time. The plaque will be collected using sterilized toothpicks. Two plaque samples will be collected from each child. Anteriorly, this will be gathered from the buccal and palatal surface of the upper incisors and canines. While posteriorly, the plaque sample will be collected from the upper and lower molars. Finally, each plaque sample will be inoculated in separate vials; each vial contains 1 ml sterile brain heart infusion broth and will be sent to the lab. After 14 days, another plaque sample will be collected as previously mentioned.

  Baseline and after 2 weeks

• Assessment of Patient's Acceptance

  Using Visual Analogue Scale (VAS).Each patient will receive the scale form and instructed to place a vertical mark according his or her personal rating of the preparation received during the treatment period on a horizontal line scaled from 0 to 10 where 0 presented for unacceptable and 10 for acceptable.

  After 2 weeks of treatment

Study Arms (2)

Propolis chewing gum

EXPERIMENTAL

2 % pure raw propolis, 20-35% gum base, 2.5% flavors, 0.3% sorbitol and 0.3% coloring substance. Children will be instructed to chew the specially prepared propolis chewing gum for at least 20 minutes, twice daily, after breakfast and before bedtime.

Combination Product: Propolis chewing gum

Propolis mouthwash

ACTIVE COMPARATOR

The formulation includes 2% pure raw propolis, 40 ml flavors, 150 ml propylene glycol, 60 gm sorbitol, 0.1 g coloring substance and water. Children will be instructed to rinse using the prepared propolis mouthwash for 1 min, twice a day, after breakfast and before bedtime.

Combination Product: Propolis mouthwash

Interventions

Propolis chewing gum COMBINATION_PRODUCT

Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.

Propolis chewing gum

Propolis mouthwash COMBINATION_PRODUCT

Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.

Propolis mouthwash

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with high caries risk; who have any one of the following condition: visible cavities or radiographic penetration into the dentin, white spots on smooth surfaces, restorations within last three years due to caries.
• Free of any systemic condition.
• Cooperative children according to Frankl rating scale including positive and definitely positive scores.
• Parental acceptance

You may not qualify if:

• Previous use of any propolis containing products.
• Received any antibiotic 2 weeks before or during the study.
• Oral infection that compromises the mastication process.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (4)

• Imfeld T. Chewing gum--facts and fiction: a review of gum-chewing and oral health. Crit Rev Oral Biol Med. 1999;10(3):405-19. doi: 10.1177/10454411990100030901.

  PMID: 10759416 BACKGROUND

• Balouiri M, Sadiki M, Ibnsouda SK. Methods for in vitro evaluating antimicrobial activity: A review. J Pharm Anal. 2016 Apr;6(2):71-79. doi: 10.1016/j.jpha.2015.11.005. Epub 2015 Dec 2.

  PMID: 29403965 BACKGROUND

• Santos FA, Bastos EM, Maia AB, Uzeda M, Carvalho MA, Farias LM, Moreira ES. Brazilian propolis: physicochemical properties, plant origin and antibacterial activity on periodontopathogens. Phytother Res. 2003 Mar;17(3):285-9. doi: 10.1002/ptr.1117.

  PMID: 12672164 BACKGROUND

• Dodwad V, Kukreja BJ. Propolis mouthwash: A new beginning. J Indian Soc Periodontol. 2011 Apr;15(2):121-5. doi: 10.4103/0972-124X.84379.

  PMID: 21976834 BACKGROUND

Study Officials

• Hend S El-Allaky

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Nadia A Wahba

  Alexandria University

  STUDY DIRECTOR

• Dalia AM Talaat

  Alexandria University

  STUDY DIRECTOR

• Azza S Zakaria

  Faculty of Pharmacy, Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator and the participants will not be blinded to the treatment type as each group has to be given different instruction according to their treatment protocol. However, the statistician and the microbiologist will be blinded to the treatment group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each)

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: December 20, 2017
• Primary Completion: February 10, 2019
• Study Completion: February 20, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

EG (1)